FDA approves Advisa MRI Pacemaker System

13th February 2013

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On 13 February, the US Food and Drug Administration (FDA) approved the Advisa DR MRI SureScan pacing system. The Advisa MRI system is Medtronic’s second-generation MR-Conditional pacemaker and, according to a company release, is the first system to combine the most advanced pacing technology with proven magnetic resonance imaging (MRI) access.

The Advisa MRI system was specifically tested and approved for use as labeled with MRI scanners in the USA. The FDA approval was supported with results from the Advisa MRI clinical trial. In the study, none of the 156 patients scanned showed any MRI-related complications.

The new system includes an Advisa MRI device and two CapSureFix MRI SureScan leads, which must be used together.

“Your physician can implant a pacemaker with advanced options that will allow for broad access to MRI scanning,” said J Rod Gimbel, principal investigator of the Advisa MRI clinical trial, (Cardiology Associates of East Tennessee, Knoxville, USA) “MRI is just so very important and traditional pacemakers not FDA approved for MRI scanning often prevent the patient from having an MRI when they need it. With more than 85% of pacemaker patients being at least 65 years old and having multiple comorbidities for which MRI may be needed, it is key that physicians and patients have a pacing system that allows MRI imaging as a diagnostic procedure.”

Until the availability of Medtronic’s SureScan pacing systems, patients with pacemakers in the USA have been contraindicated from receiving MRI scans because of potential interactions between the MRI and device function. According to Kalin R and Stanton MS (PACE 2005; 28:326-328), up to 75% of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.

About Advisa MRI Pacing System

Medtronic’s Advisa MRI pacing system provides physicians with innovative technology that will benefit their patients, including the MVP (Managed Ventricular Pacing) algorithm, which is proven to reduce unnecessary ventricular pacing. Additional Advisa features include:

Complete automaticity with Ventricular and Atrial Capture Management (VCM and ACM) to eliminate manual threshold checks and extend longevity of the device by up to one year.

Diagnostics, such as the Cardiac Compass Report, and AF management tools that assist physicians in the early detection and treatment of atrial fibrillation.

Rate Drop Response that identifies abrupt cardiac slowing and responds by pacing the heart at an elevated rate, which may reduce the frequency of syncope in patients with apparent cardio-inhibitory vasovagal syncope.

Highupper tracking rate to provide pacing support at higher heart rates for active and younger patients.